Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- GLOBAL FUNCTION
研究概览
简要总结
The main objective is to assess the efficacy of Acceptance & Commitment Therapy (ACT) in group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as anxiety, depression, pain or global function. 3.- To evaluate the usefulness or electroencephalographic cordance as a prognostic variable of the treatment.
HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome variables (pain, anxiety, depression, global function) in fibromyalgia, and it is cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.
DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group Acceptation & Commitment Therapy or 2.- Treatment as usual by his general practitioner. Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group of patients.
详细描述
The main outcome will be pain acceptance. Other outcome measures will be global function (assessed with the Fibromyalgia Impact Questionnaire, FIQ), cost-effectiveness (evaluated by the Client Service Receipt Inventory, CSRI) and electroencephalographic cordance. The mediating variables included are anxiety and depression (assessed with the Hospital Anxiety and Depression scale, HADS) and pain (measured with an analog visual scale). A psychiatric interview will be administered to the participants to diagnose Posttraumatic Stress Disorder. Statistical analysis will be carried out for intention to treat, and using the method Last Observation Carried Forward. A Repeated Measures Mixed Model will be used to study the main outcome. All calculations will be made with two tails and a significance of 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 year old
- •Discontinuation drug treatment 7 days before the start of the trial
- •Not having received psychological treatment previously or at least in the last 2 years
- •Ability to understand Spanish
- •Given consent to participate in the study
排除标准
- •Age: <18 year old and > 65 year old
- •Clinical or psychological disease that, at investigator's opinion, can interfere the psychological examination or the adherence to psychotherapy (dementia, alcohol or drug abuse, psychosis, severe personality disorder)
研究组 & 干预措施
ACT in group
Patients assigned to this arm will receive Acceptation and Commitment Therapy (ACT) in groups of 8-12 patients. Intervention has been protocolized. Therapy will be administered by two experienced therapists (psychologists).
干预措施: ACT in group (Behavioral)
Improved Treatment as usual by General practitioner
Patients assigned to this arm will receive treatment as usual by their General Practitioner in the Primary Care center. To enhance treatment, investigators participating in the trial will receive the Guidelines for fibromyalgia treatment in Primary Care handed by Health Service in Aragón.
干预措施: Improved treatment as usual by General Practitioners (Behavioral)
结局指标
主要结局
GLOBAL FUNCTION
时间窗: At month 9
GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.
GLOBAL FUNCTION
时间窗: At baseline
GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.
GLOBAL FUNCTION
时间窗: At month 3
GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.
GLOBAL FUNCTION
时间窗: At month 6
GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.
次要结局
- DEMOGRAPHIC AND CLINICAL DATA(At Baseline)
- PAIN CATASTROPHIZING(At month 6)
- ANXIETY AND DEPRESSION(At month 6)
- PSYCHIATRIC DIAGNOSIS(At baseline)
- PAIN(At month 6)
- COST-EFFECTIVENESS ANALYSIS(At month 9)
- PAIN ACCEPTANCE(At month 9)
- CORDANCE(At month 3)
- PAIN CATASTROPHIZING(At Baseline)
- ANXIETY AND DEPRESSION(At Baseline)
- PAIN(At baseline)
- COST-EFFECTIVENESS ANALYSIS(At Baseline)
- PAIN ACCEPTANCE(At Baseline)
- CORDANCE(At baseline)
- PAIN CATASTROPHIZING(At month 3)
- ANXIETY AND DEPRESSION(At month 3)
- PAIN(At month 3)
- COST-EFFECTIVENESS ANALYSIS(At month 3)
- COST-EFFECTIVENESS ANALYSIS(At month 6)
- PAIN ACCEPTANCE(At month 3)
- PAIN ACCEPTANCE(At month 6)
研究者
Dr. Marta Alda
Principal Investigator
Hospital Miguel Servet